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#405: AI Tools in Clinical Trials: Regulatory Considerations for Radiologic and Pathologic Assessment
Monday June 15, 2026 11:00am - 12:15pm EDT
109AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-514-L04-P; CME 1.25; RN 1.25

AI offers promise in standardizing radiology and pathology by reducing inter-human variability. This session examines opportunities, risks, regulatory oversight, and the role of reference datasets for tool validation.

Learning Objectives

Describe the current landscape and practical applications of AI-based diagnostic tools; Examine potential regulatory frameworks and strategies to ensure oversight and reliability of AI-based diagnostics; Identify key considerations in developing reference datasets to support validation of AI tools.

Chair

Hillary Andrews, PHD

Speaker

Industry Perspective
Alain Silk, PHD

Patient Advocate Perspective
Jason Binder, MA

Industry Perspective
Mike Montalto, PHD


Speakers
JB

Jason Binder

Founder & CEO, Ember, United States
Jason Binder is the Founder and CEO of Ember, building the first continuous, real-world dataset of patient and caregiver decision-making in oncology. A former pharma data and clinical strategy leader with experience at AstraZeneca, Genentech, and Merck, he focuses on integrating AI... Read More →
avatar for Alain Silk

Alain Silk

Senior Director, Regulatory Affairs, Tempus AI, Inc., United States
Alain Silk is a Senior Director of Regulatory Affairs at Tempus AI, a technology company applying analytic tools to provide data driven insights from clinical and molecular data. Dr. Silk has over a decade of experience as a medical device regulatory professional across diverse diagnostic... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

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